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What is the most important information I should know about amlodipine and atorvastatin?

Amlodipine and atorvastatin can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

You should not use this medication if you are allergic to amlodipine (Norvasc) or atorvastatin (Lipitor), or if you are breast-feeding a baby.

Before taking amlodipine and atorvastatin, tell your doctor if you have ever had liver or kidney disease, heart disease, diabetes, or a thyroid disorder, or if you drink more than 2 alcoholic beverages daily.

In rare cases, amlodipine and atorvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

Avoid eating foods that are high in fat or cholesterol. Amlodipine and atorvastatin will not be as effective in lowering your cholesterol if you do not follow a cholesterol-lowering diet plan.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage.

Some medicines can cause unwanted or dangerous effects when used with amlodipine and atorvastatin. Tell your doctor about all medicines you use, and those you start or stop using during your treatment with amlodipine and atorvastatin.

What is amlodipine and atorvastatin?

Atorvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." Atorvastatin reduces levels of "bad" cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood, while increasing levels of "good" cholesterol (high-density lipoprotein, or HDL).

Amlodipine is in a group of drugs called calcium channel blockers. Amlodipine relaxes the blood vessels, improving blood flow and making it easier for the heart to pump.

The combination of amlodipine and atorvastatin is used to treat high blood pressure (hypertension) or chest pain (angina), and to lower the risk of stroke, heart attack, and other heart complications in people with type 2 diabetes, coronary heart disease, or other risk factors.

Amlodipine and atorvastatin is used in adults and children who are at least 10 years old.

Amlodipine and atorvastatin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking amlodipine and atorvastatin?

You should not use this medication if you are allergic to amlodipine (Norvasc) or atorvastatin (Lipitor), if you are pregnant or breast-feeding, or if you have liver disease.

To make sure amlodipine and atorvastatin is safe for you, tell your doctor if you have:

history of liver disease;

history of kidney disease;

heart disease;

diabetes;

a thyroid disorder; or

if you drink more than 2 alcoholic beverages daily.

Tell your doctor about all other medications you use. Certain other drugs can increase your risk of serious muscle problems, and it is very important that your doctor knows if you are using any of them:

In rare cases, amlodipine and atorvastatin can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. This condition may be more likely to occur in older adults and in people who have kidney disease or poorly controlled hypothyroidism (underactive thyroid).

FDA pregnancy category X. This medication can harm an unborn baby or cause birth defects. Do not take amlodipine and atorvastatin if you are pregnant.Stop taking this medication and tell your doctor right away if you become pregnant. Use effective birth control to avoid pregnancy while you are taking amlodipine and atorvastatin.

It is not known whether amlodipine and atorvastatin passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

How should I take amlodipine and atorvastatin?

Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Amlodipine and atorvastatin is usually taken once a day, with or without food. Take the medicine at the same time each day. Your doctor may occasionally change your dose to make sure you get the best results.

Do not break an amlodipine and atorvastatin tablet. Tell your doctor if you have trouble swallowing the pill.

You may need to stop using amlodipine and atorvastatin for a short time if you have:

uncontrolled seizures;

an electrolyte imbalance (such as high or low potassium levels in your blood);

severely low blood pressure;

a severe infection or illness; or

surgery or a medical emergency.

While using amlodipine and atorvastatin, you may need frequent blood tests at your doctor's office. Your kidney function may also need to be checked.

Amlodipine and atorvastatin is only part of a complete program of treatment that also includes diet, exercise, and weight control. Follow your diet, medication, and exercise routines very closely.

You may need to take amlodipine and atorvastatin on a long-term basis for the treatment of high cholesterol. If you are being treated for high blood pressure, keep using this medication even if you feel fine. High blood pressure often has no symptoms.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking amlodipine and atorvastatin?

Avoid eating foods that are high in fat or cholesterol. This medication will not be as effective in treating your condition if you do not follow the diet plan recommended by your doctor.

Avoid drinking alcohol. It can raise triglyceride levels and may increase your risk of liver damage. Alcohol can also further lower blood pressure and can increase some of the side effects of amlodipine and atorvastatin.

Grapefruit and grapefruit juice may interact with atorvastatin and lead to potentially dangerous effects. Avoid the use of grapefruit products while taking amlodipine and atorvastatin.

What are the possible side effects of amlodipine and atorvastatin?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using amlodipine and atorvastatin and call your doctor at once if you have:

unexplained muscle pain, tenderness, or weakness;

fever, unusual tiredness, and dark colored urine;

swelling, weight gain, urinating less than usual or not at all;

severe drowsiness, feeling like you might pass out;

pounding heartbeats or fluttering in your chest;

worsening chest pain;

chest pain spreading to the arm or shoulder, nausea, sweating, general ill feeling; or

Tell your doctor about all medicines you use, and those you start or stop using during your treatment with amlodipine and atorvastatin, especially:

Where can I get more information?

Your pharmacist can provide more information about amlodipine and atorvastatin.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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